Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

PHASE2UnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

July 31, 2021

Study Completion Date

July 31, 2021

Conditions
Multiple Myeloma
Interventions
DRUG

Carfilzomib

"DOSING REGIMEN.~The regimen will have 2 parts:~Part 1. Induction. Nine 5 weeks cycles (35-days each) of weekly Carfilzomib Melphalan Prednisone are planned Carfilzomib. 36, 45, 56 or 70 mg/m² on days 1, 8, 15, 22 IV route followed by a 13-day rest period per 35-days cycle. Patients will start the first cycle day 1 with 20mg/m².~In combination with oral Melphalan 0.25mg/kg/j and oral prednisone 60mg/m², both on days 1 to 4.~Part 2. Maintenance. Carfilzomib. 36 mg/m² weekly, every two weeks IV route for 1 year. Melphalan and Prednisone is not pursued at this phase of the study."

Trial Locations (33)

13273

Hématologie, Institut Paoli Calmette, Marseille

21000

Hématologie Clinique, CHU, Hôpital d'Enfants, Dijon

24019

Unité de Recherche Clinique - CH Perigueux, Périgueux

25030

Hôpital Jean Minjoz, Besançon

30029

CHU Nimes CAREMEAU, Nîmes

31059

Hématologie, IUCT oncopole, Toulouse

33076

Institut Bergonie, Bordeaux

33300

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

33604

Hôpital Haut-Leveque, Pessac

44035

CHRU, Hôtel Dieu, Nantes

51092

Hématologie Clinique, Hôpital Robert Debré, CHU Reims, Reims

54511

CHRU, Hôpitaux de Brabois, Vandœuvre-lès-Nancy

57038

Hôpital Notre Dame de Bon Secours, Metz

59020

Hôpital St Vincent de Paul - GH-ICL, Lille

59037

Chru Lille, Lille

64109

Centre Hospitalier de la côte basque, Bayonne

68024

CH Louis Pasteur, Colmar

68100

Hôpital E Muller, Mulhouse

69495

Centre Hospitalier Lyon Sud -1, Pierre-Bénite

71100

Centre Hospitalier William Morey, Chalon-sur-Saône

72000

Centre Jean Bernard, Le Mans

73011

Centre Hospitalier de Chambery, Chambéry

75571

Hôpital St Antoine, Paris

75651

Groupe hospitalier Pitié Salpétrière, Paris

76290

Hopital J Monod, Montivilliers

77104

CH Meaux, Meaux

84902

Centre Hospitalier H. Duffaut, Avignon

85025

Centre hospitalier départemental La Roche sur Yon, La Roche-sur-Yon

87000

CHU de Limoges, Limoges

91106

CH Francilien, Corbeil-Essonnes

92140

Hôpital St Antoine Béclére, Clamart

94010

CHU Henri Mondor, Créteil

06202

Centre de NICE 2/ Hôpital Archet, Nice

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

University Hospital, Lille

OTHER

NCT02302495 - Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma | Biotech Hunter | Biotech Hunter